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Sleep and Circadian Rhythms in Mechanically Ventilated Patients

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ClinicalTrials.gov Identifier: NCT01276652
Recruitment Status : Completed
First Posted : January 13, 2011
Results First Posted : September 26, 2017
Last Update Posted : September 26, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study examines the feasibility of assessing sleep and circadian rhythmicity in critically ill patients undergoing mechanical ventilation. Secondarily, it will examine the feasibility of reducing subject exposure to environmental light and noise and of delivering routine care according to classical day/night routines.

Condition or disease Intervention/treatment
Respiratory Failure Critical Illness Behavioral: Environmental modification

Detailed Description:
Over 1 million patients develop respiratory failure annually in the United States; yet, the sleep of patients undergoing mechanical ventilation has received little attention. This protocol enrolls acutely ill medical patients undergoing mechanical ventilation. The feasibility of assessing sleep and circadian rhythmicity through the use of continuous bedside polysomnography and the measurement of core body temperature and urinary hormonal levels at frequent intervals will be explored. As a secondary goal, the feasibility of delivering routine care according to classical day/night routines, and of employing various noise and light reduction strategies at night, will be explored in a subset of subjects.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects were randomized in 1:1 fashion to receive the Environmental Modification protocol or usual care. Subsequently a third, observational arm was opened to acquire more physiologic data.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Sleep and Circadian Rhythms in Mechanically Ventilated Patients: a Feasibility and Mechanistic Study.
Study Start Date : November 2001
Primary Completion Date : December 2008
Study Completion Date : December 2008
Arms and Interventions

Arm Intervention/treatment
Active Comparator: Environmental modification
Subjects assigned to this group receive the environmental modification intervention for 48 hours beginning the morning after enrollment.
Behavioral: Environmental modification
Environmental modification consists of nursing-related efforts to optimize daytime light exposure, to minimize nighttime light and noise exposure, and to batch nursing care at night.
No Intervention: Usual care (randomized)
Usual care is provided for the first 48 hours. Subsequently, in the initial protocol, subjects received 48 hours of the environmental modification intervention so long as they remained in the ICU during this time. The opportunity to receive the "Delayed" intervention was later removed from the protocol.
No Intervention: Usual care (observational)
Usual care was provided.

Outcome Measures

Primary Outcome Measures :
  1. Percentage of Subjects Who Successfully Undergo Continuous Bedside Polysomnography for at Least 24 Hours. [ Time Frame: Average 4 days (patients followed to hospital discharge) ]
    This study assesses the feasibility of studying sleep and circadian rhythmicity in acutely ill, mechanically ventilated patients through the application of continuous bedside polysomnography. Feasibility will be assessed by determining the percentage of enrolled subjects who undergo at least 24 hours of continuous bedside polysomnography.

Secondary Outcome Measures :
  1. Subject Tolerance of the Environmental Modification Protocol [ Time Frame: Average 4 days (patients followed to hospital discharge) ]
    This outcome measure will examine, in a preliminary fashion, subject tolerance of the environmental modification protocol. Tolerance will be assessed through qualitative interviews performed by the PI with the subjects.

Other Outcome Measures:
  1. Occurrence of REM Sleep [ Time Frame: Average 4 days (patients followed to hospital discharge) ]
    Occurrence of identifiable rapid eye movement (REM) sleep in each subject.

  2. Normal Timing of 6-sulfatoxymelatonin Excretion [ Time Frame: Average 4 days (patients followed to hospital discharge) ]
    The number of participants in each group who exhibit normal timing of 6-sulfatoxymelatonin excretion will be reported. The normal timing of peak melatonin excretion was considered to be between midnight and 05:00. Subjects in whom the melatonin onset occurred after midnight or the acrophase occurred after 05:00 were considered to be phase delayed, while patients whose acrophase occurred prior to midnight were considered to be phase advanced.

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults undergoing mechanical ventilation in the medical intensive care unit.

Exclusion Criteria:

  • Central nervous system disease (stroke, seizure, dementia, etc)
  • Metabolic or hypoxic encephalopathy
  • Confirmed or suspected drug overdose
  • Currently receiving neuromuscular blockers
  • Coma
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01276652

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Iowa
National Heart, Lung, and Blood Institute (NHLBI)
The Brain Research Foundation
University of Chicago
Principal Investigator: Brian K Gehlbach, MD University of Chicago
Principal Investigator: Jesse Hall, MD University of Chicago
More Information

Responsible Party: Brian Gehlbach, Clinical Associate Professor of Medicine, University of Iowa
ClinicalTrials.gov Identifier: NCT01276652     History of Changes
Other Study ID Numbers: SleepICU111
5K23HL088020 ( U.S. NIH Grant/Contract )
First Posted: January 13, 2011    Key Record Dates
Results First Posted: September 26, 2017
Last Update Posted: September 26, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: As this is a pilot study, there are no plans to share IPD.

Keywords provided by Brian Gehlbach, University of Iowa:
Circadian rhythmicity

Additional relevant MeSH terms:
Respiratory Insufficiency
Critical Illness
Respiration Disorders
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes